Senior Quality Engineer

Real; California (MO); On-site; USD 120,000 - 160,000; Full time

Job summary

Specialist Staffing Group is seeking an experienced Senior Quality Engineer for an onsite role in Menlo Park, CA, to lead quality activities across development, transfer, and manufacturing readiness for a Class III medical device.

The candidate will partner with R&D, Operations, Clinical, and Regulatory Affairs, driving risk management per ISO 14971, DHF/DMR, V&V, and CAPA processes while ensuring compliance with FDA QSR 21 CFR 820 and ISO 13485.

Qualifications

• Bachelor's degree in Engineering or Life Sciences required.
• 8+ years medical device quality engineering experience with Bachelor's, or 6+ with Master's.
• Experience with ISO 14971 risk management, DHF/DMR, design controls.
• Knowledge of FDA QSR 21 CFR 820 and ISO 13485.

Responsibilities

• Serve as Quality representative on NPD teams, ensuring design controls, DHF, and documentation.
• Lead risk management activities per ISO 14971 including FMEAs and residual risk.
• Develop and execute V&V strategies with traceability and test method validation.
• Support design transfer and manufacturing readiness including DMR inputs and lot release.
• Review and approve validation protocols and reports (IQ/OQ/PQ, sterilization, packaging).
• Drive biocompatibility planning per ISO 10993 with cross-functional teams.
• Lead investigations of complaints, CAPA, deviations, and supplier quality issues.
• Assess ECOs for quality impact and ensure verification/validation.
• Support supplier qualification, audits, and incoming inspection.
• Analyze quality metrics and drive continuous improvement.
• Mentor team members and promote quality best practices.

Skills

Design controls

DHF/DMR documentation

Risk management

CAPA

NCR/NCMR

Supplier quality

Change control

FDA 21 CFR 820

ISO 13485

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Engineering

Master's degree

Tools

Minitab

Job description

A fast-growing clinical-stage medical device company is seeking an experienced Senior Quality Engineer to play a key role in the development and commercialization of an innovative Class III medical device technology. This position will partner closely with R&D, Operations, Clinical, and Regulatory Affairs teams, leading quality engineering activities throughout product development, verification and validation, risk management, design transfer, and manufacturing readiness.

Please note: This is an onsite position based in Menlo Park, CA. Relocation assistance is not available. Candidates must currently reside in the area or be willing to relocate at their own expense. No visa sponsorship or transfer sponsorship is available at this time.

Key Responsibilities

• Serve as the Quality representative on new product development teams, ensuring compliant execution of design controls, Design History File (DHF) deliverables, and product development documentation.
• Lead and maintain risk management activities in accordance with ISO 14971, including hazard analyses, FMEAs, risk controls, traceability, and residual risk evaluations.
• Develop and execute verification and validation (V&V) strategies, including protocol development, requirements traceability, test method validation, and report approvals.
• Support design transfer and manufacturing readiness activities, including inspection plans, sampling strategies, acceptance criteria, Device Master Record (DMR) inputs, and lot release processes.
• Review and approve validation protocols and reports, including IQ/OQ/PQ activities, sterilization validation, packaging validation, and shelf‑life studies.
• Drive biocompatibility planning and execution in accordance with ISO 10993, coordinating with cross‑functional teams and external laboratories.
• Lead investigations related to complaints, nonconformances, deviations, and supplier quality issues, implementing effective CAPAs and root cause analyses.
• Assess engineering change orders (ECOs) for quality impact and ensure appropriate verification and validation activities are completed.
• Support supplier qualification, audits, incoming inspection programs, and supplier performance monitoring.
• Analyze quality metrics and trends, providing recommendations for continuous improvement initiatives.
• Mentor team members and promote quality best practices across the organization.

Required Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, or a related technical field.
• Minimum of 8 years of medical device quality engineering experience with a Bachelor's degree, or 6 years with a Master's degree.
• Strong experience with design controls, DHF/DMR documentation, and risk management activities under ISO 14971.
• Working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
• Experience with CAPA, NCR/NCMR processes, supplier quality, and change control systems.
• Strong communication, organizational, and cross‑functional collaboration skills.
• Ability to work in a hands‑on, fast‑paced product development environment.

Preferred Qualifications

• Experience with sterilization processes (EO, gamma, e‑beam), sterile barrier systems, packaging validation, and shelf‑life testing.
• Familiarity with biocompatibility programs under ISO 10993.
• Experience supporting IDE, PMA, or other premarket regulatory submissions.
• Supplier audit experience and contract manufacturing oversight.
• Knowledge of statistical methods such as SPC, DOE, sampling plans, and Minitab.
• Lean, Six Sigma, or related process improvement training.
• Certified Quality Engineer (CQE) certification preferred.

Why Join?

This is an opportunity to join an innovative medical device company developing breakthrough technology for patients with severe pulmonary disease. The role offers significant exposure to product development, clinical‑stage activities, and commercialization efforts while working alongside an experienced cross‑functional team.

No visa sponsorship or employment‑based immigration support is available for this position now or in the future.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct‑hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.